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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ASTRA-OCT Spine System - M824A3P55201

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 20mm
SPINECRAFT, LLC
A3P-5520
Not in Commercial Distribution

  • 00193082080128 ()
  • M824A3P55201 ()
A3P-5520

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5515R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 15mm
SPINECRAFT, LLC
A3P-5515R
Not in Commercial Distribution

  • 00193082080906 ()
  • M824A3P5515R1 ()
A3P-5515R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5050R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-5050R
Not in Commercial Distribution

  • 00193082080890 ()
  • M824A3P5050R1 ()
A3P-5050R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5045R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 45mm
SPINECRAFT, LLC
A3P-5045R
Not in Commercial Distribution

  • 00193082080883 ()
  • M824A3P5045R1 ()
A3P-5045R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5040R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-5040R
Not in Commercial Distribution

  • 00193082080876 ()
  • M824A3P5040R1 ()
A3P-5040R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5035R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 35mm
SPINECRAFT, LLC
A3P-5035R
Not in Commercial Distribution

  • 00193082080869 ()
  • M824A3P5035R1 ()
A3P-5035R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5030R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 30mm
SPINECRAFT, LLC
A3P-5030R
Not in Commercial Distribution

  • 00193082080852 ()
  • M824A3P5030R1 ()
A3P-5030R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45401

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-4540
Not in Commercial Distribution

  • 00193082079979 ()
  • M824A3P45401 ()
A3P-4540

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45381

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 38mm
SPINECRAFT, LLC
A3P-4538
Not in Commercial Distribution

  • 00193082079962 ()
  • M824A3P45381 ()
A3P-4538

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45361

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 36mm
SPINECRAFT, LLC
A3P-4536
Not in Commercial Distribution

  • 00193082079955 ()
  • M824A3P45361 ()
A3P-4536

  • Spinal bone screw, non-bioabsorbable
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